GCP Laboratories Inc recalls Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major
GCP Laboratories is recalling Major Infants' Gas Relief Drops (1 fl oz) because of microbial contamination in non-sterile product. This may pose a risk of infection in infants.
Lower-risk recall
Microbial Contamination of Non-Sterile Product.
Contact the company & request your remedy
What happened, in plain English
GCP Laboratories is recalling Major Infants' Gas Relief Drops due to microbial contamination in non-sterile product. This could lead to infection in infants who use the product. Read more at govinfonow.com/recall/37925-gcp-laboratories-recalls-infants-gas-relief-drops-due-to-microbial.
Source Summary by GovInfoNow · govinfonow.com/recall/37925-gcp-laboratories-recalls-infants-gas-relief-drops-due-to-microbial · Updated October 5, 2026 · FDA enforcement record: FDA #D-0126-2020
Cite this page
“GCP Laboratories recalls infants gas relief drops due to microbial contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37925-gcp-laboratories-recalls-infants-gas-relief-drops-due-to-microbial. Based on FDA recall #D-0126-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0126-2020%22&limit=1).
Why it’s dangerous
The product was found to have microbial contamination, meaning harmful bacteria or other microorganisms could be present. This is a non-sterile product, so it's not meant to be sterile and could cause infection if used improperly.
Who’s affected
Infants who use Major Infants' Gas Relief Drops are at risk. Parents and caregivers should check if their child uses this product.
How to tell if you have this one
Check for the 1 fl oz (30 mL) bottle labeled 'Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP'. The product was distributed by Major Pharmaceuticals and has NDC 0904-5194-30 and lot number WBD003.
- Brand
GCP Laboratories- Category
Drug
What to do — step by step
Check Product
Look for the 1 fl oz (30 mL) bottle labeled 'Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP'.
Questions people ask
Is this product safe for infants?
The product has been recalled due to microbial contamination, so it may not be safe for infants. Do not use this product.
What should I do if I have this product?
Check the product label for the NDC 0904-5894-30 and lot number WBD003. If you have this product, stop using it and contact the manufacturer for further instructions.
Is there a risk of serious injury?
The recall is for microbial contamination, which could lead to infection in infants. However, the product is not intended to be sterile, so the risk is considered low.
Contact GCP Laboratories
We’ve drafted a message you can send GCP Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0126-2020 — GCP Laboratories GCP Laboratories Hello, I own a GCP Laboratories that is covered by recall D-0126-2020 from GCP Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0126-2020 (September 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0126-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.